a study evaluating the safety and efficacy of glofitamab + gemcitabine + oxaliplatin in u.s. patients with relapsed or refractory diffuse large b-cell lymphoma

Conditions: Lymphoma

Summary: the purpose of the study is to evaluate glofitamab + gemcitabine + oxaliplatin in participants in the united states, including under-represented racial and ethnic populations, that have relapsed or refractory (r/r) diffuse large b-cell lymphoma (dlbcl).


Eligibility criteria:
inclusion criteria: * histologically confirmed dlbcl, not otherwise specified (nos) * relapsed (disease that has recurred following a response that lasted ≥ 6 months after completion of the last line of therapy) or refractory ( disease that did not respond to or that progressed \< 6 months after completion of the last line of therapy) disease * at least one prior line of systemic therapy * participants who have failed only one prior line of therapy must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant (asct) * at least one bi-dimensionally measurable (\> 1.5 cm) nodal lesion, or one bi-dimensionally measurable (\> 1 cm) extranodal lesion, as measured on ct scan * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 exclusion criteria: * prior enrollment in study go41944 (starglo; nct04408638) * participant has failed only one prior line of therapy and is a candidate for stem cell transplantation * history of transformation of indolent disease to dlbcl * high-grade b-cell lymphoma with myc and bcl2 and/or bcl6 rearrangements, and high-grade b-cell lymphoma nos, as defined by 2016 who guidelines * primary mediastinal b-cell lymphoma * history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products * prior treatment with glofitamab or other bispecific antibodies targeting both cd20 and cd3 * prior treatment with gemcitabine or oxaliplatin * peripheral neuropathy or paresthesia assessed to be grade \>/= 2 according to nci ctcae v5.0 at enrollment * treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to first study treatment * treatment with monoclonal antibodies for the purposes of treating cancer within 4 weeks prior to first study treatment * primary or secondary cns lymphoma at the time of recruitment or history of cns lymphoma * prior cns involvement that has been definitively treated and confirmed via mri or cerebrospinal fluid analysis to be in complete remission is permissible * current or history of cns disease, such as stroke, epilepsy, cns vasculitis, or neurodegenerative disease * history of other primary malignancy, with exceptions defined by the protocol * significant or extensive cardiovascular disease, or significant pulmonary disease * known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (exclusing fungal infections of nail beds) at study enrollment or any major episode of infection within 4 weeks prior to the first study treatment * documented severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection within 6 months of first study treatment, or positive sars-cov-2 test within 7 days prior to enrollment * suspected or latent tuberculosis * positive test results for hepatitis b (hbv) or hepatitis c (hcv) * known or suspected chronic active epstein-barr viral infection * known or suspected history of hemophagocytic lymphohistiocytosis (hlh) * known history of progressive multifocal leukoencephalopathy * prior solid organ transplantation * prior allogenic stem cell transplant * active autoimmune disease requiring treatment * prior treatment with systemic immunosuppressive medications within 4 weeks prior to first dose of study treatment * ongoing systemic corticosteroid use which, in the opinion of the investigator, puts the patient at increased risk of steroid-related iatrogenic adrenal insufficiency * recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis * clinically significant history of cirrhotic liver disease